ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER— 510(k) K930129
UnknownArrow Intl., Inc.
FDA 510(k) clearance K930129 for ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER, Unknown on 1994-03-28. Applicant: Arrow Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Reading, PA, US
Recent devices under product code LJS
view all- K260929 — Neonav ECG Tip Location System
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252792 — PM2 System with ECGuide Connector
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Arrow Intl., Inc.
view all- K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
- K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
- K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES
- K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
- K071111 — NON-ABSORBABLE SILK SUTURE
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K930129
K-number listed on FDA's recall record- Z-2021-2018 — Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
- Z-1228-2017 — Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K930129.
Data sourced from openFDA. This site is unofficial and independent of the FDA.